Bisoprolol Fumarate

Product NDC: 21695-670
11-digit product format: 216950670
Labeler code: 21695
Product ID: 21695-670_d82243b9-3e56-4a2b-8750-cb95ec106885
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bisoprolol fumarate
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA078635
Marketing category: ANDA
Marketing start: 2009-09-21
Marketing end: 0000-00-00
Substance: BISOPROLOL FUMARATE
Active strength: 10 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-670		I	Inactivated by FDA	2026-08-03
excluded package	package	21695-670	21695-670-30	I	Inactivated by FDA	2026-08-03
excluded package	package	21695-670	21695-670-90	I	Inactivated by FDA	2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 66 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-670-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-670-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-670-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-670-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-670-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-670-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-670-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-670-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-670-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-670-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-670-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-670-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-670-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-670-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-670-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-670-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-670-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-670-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-670-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-670-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-670-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-670-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-670-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-670-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-670-90	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-670-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-670-90	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-670-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-670-90	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-670-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-670-90	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-670-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-670-90	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-670-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-670-90	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-670-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-670-90	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-670-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-670-90	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-670-30	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078635-001	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18
A078635-002	BISOPROLOL FUMARATE	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A078635-001	AB
A078635-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078635-001	BISOPROLOL FUMARATE	5MG	TABLET / ORAL	AB		2009-08-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078635-002	BISOPROLOL FUMARATE	10MG	TABLET / ORAL	AB	RS	2009-08-18	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078635-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078635-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078635-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078635-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078635-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078635-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078635-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078635-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078635-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078635-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078635-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078635-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078635-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078635-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078635-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078635-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078635-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078635-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078635-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078635-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078635-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078635-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078635-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078635-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078635-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078635-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078635-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078635-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078635-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078635-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078635-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078635-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078635-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078635-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078635-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078635-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078635-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078635-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078635-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078635-002	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
97e4a60d-917d-ef62-dc8a-bd557b62b708	Product name	7	20260129
9b303cd4-3186-2454-5706-3137e8b2dfd2	Product name	4	20221110

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-670-30	2019-09-24	C162847	48780-1	934fe258-47f4-48b1-e053-8cdaa90a720a	Bisoprolol Fumarate Tablets USP
21695-670-90	2019-09-24	C162847	48780-1	934fe258-47f4-48b1-e053-8cdaa90a720a	Bisoprolol Fumarate Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-670-30	Bisoprolol Fumarate	30 in 1 BOTTLE, PLASTIC	TABLET	30		1
21695-670-90	Bisoprolol Fumarate	90 in 1 BOTTLE, PLASTIC	TABLET	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-670-30	EA - Each	21695-670	8f25c405-9032-4cf4-a643-373ff7277115	1	2012-07-24
21695-670-90	EA - Each	21695-670	39e137f4-fe4b-44f4-8437-aa6e1b9ae7c8	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BISOPROLOL FUMARATE	ACTIVE INGREDIENT	UR59KN573L	BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]	1
BISOPROLOL	ACTIVE MOIETY	Y41JS2NL6U	BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-670	BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 2 package rows	20110413_d82243b9-3e56-4a2b-8750-cb95ec106885.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bisoprolol Fumarate	BISOPROLOL FUMARATE	Preferred Pharmaceuticals Inc.	c0e309f3-82c3-4629-b790-fb8538b87369	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078635 application number: ANDA078635
Bisoprolol Fumarate	BISOPROLOL FUMARATE	American Health Packaging	36b53e7f-e306-40a8-8d1b-d00695a4fe61	2024-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078635 application number: ANDA078635
Bisoprolol Fumarate	BISOPROLOL FUMARATE	Bryant Ranch Prepack	428ef54d-8828-4756-a087-a1b7b2d6b8d6	2023-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078635 application number: ANDA078635
Bisoprolol Fumarate	BISOPROLOL FUMARATE	Bryant Ranch Prepack	4f11e64c-732e-419a-bc29-9cd2ff86d0b9	2023-09-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078635 application number: ANDA078635
Bisoprolol Fumarate	BISOPROLOL FUMARATE	Unichem Pharmaceuticals (USA), Inc.	4f20df45-3f9c-4a91-b394-e93a08111ec3	2022-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078635 application number: ANDA078635
Bisoprolol Fumarate	BISOPROLOL FUMARATE	Proficient Rx LP	bce7e65a-148f-4ccd-9305-bc7331dbcca4	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078635 application number: ANDA078635

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UR59KN573L	BISOPROLOL FUMARATE	104344-23-2	BISOPROLOL FUMARATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
854901	bisoprolol fumarate 10 MG Oral Tablet	PSN	d82243b9-3e56-4a2b-8750-cb95ec106885	1
854905	bisoprolol fumarate 5 MG Oral Tablet	PSN	d82243b9-3e56-4a2b-8750-cb95ec106885	1
854901	bisoprolol fumarate 10 MG Oral Tablet	SCD	d82243b9-3e56-4a2b-8750-cb95ec106885	1
854905	bisoprolol fumarate 5 MG Oral Tablet	SCD	d82243b9-3e56-4a2b-8750-cb95ec106885	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-670-30	21695067030	30 in 1 BOTTLE, PLASTIC	Historical
21695-670-90	21695067090	90 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bisoprolol Fumarate Tablets USP	Rebel Distributors Corp	2010-12-10	HUMAN PRESCRIPTION DRUG LABEL	1